Ultrapure Water System for Hemodialysis Therapy

• Conditions: The Change of Biomarkers CRP, CBC With the Use of Ultra Pure Water System for; Hemodialysis.; The Rate of Adverse Events Such as Hypotension During Hemodialysis Therapy With Ultra Pure Water; System as Compared to Conventional Water System.

• Registration Number: NCT01400126
• Lead Sponsor: Tel Aviv Medical Center

Brief Summary

We wish to compare the effect of very clean water used for dialysis therapy (i.e ultrapure water) in comparison with the use of conventional water which are used in most dialysis units worldwide. To the best of our knowledge prospective data in that field is sparse.

Detailed Description

In observational studies, the use of very pure dialysis solution has been suggested to reduce the plasma level of CRP, IL-6 ; to improve the response to anemia to erythropoietin therapy ; to promote better nutrition as evidenced by increase in plasma albumin value , estimated dry body weight, midarm muscle circumference and urea-nitrogen appearance rate; to reduce plasma level of β2-microglobulin and pentosidine ; to dely carpal tunnel syndrome ; to slow the loss of residual renal function; and to lower cardiovascular morbidity.The aim of this study is to prospectively evaluate the effect of dialysis performed with ultra-pure water (UPW)in comparison with dialysis with the use of conventional water system. Patients enrolled into this study will be evaluated at initial period of one month treated with conventional water system (-30 to 0 days). Then water system will be switched to ultra-pure water system with the use of filter added to the dialysis machine (Gambro). After switching to UPW system the patients will be followed for a period of one year (days 0-365). Primary end point will be change in CRP. Additional parameters: Blood pressure, adverse events during dialysis, hemoglobin levels and white-blood cell counts.

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Study First Posted: 2011-07-22
• Last Update Posted: 2011-07-22
• Study Start: 2011-08
• Primary Completion: 2012-08
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. chronic hemodialysis therapy thrice weekly > 3 months of therapy
2. Signed an informed consent -

Exclusion Criteria

1. Enrolled to other study
2. Ongoing infection -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CRP	13 months

Secondary Outcome Measures

Name	Time	Method
blood pressure	13 months